The ruling is significant because plaintiffs like Fulgenzi making
“failure-to-warn” claims against generic makers have made little headway
in the wake of the 2011 U.S. Supreme Court ruling PLIVA v. Mensing. In
that case, the high court found that consumers could not bring
failure-to-warn claims against generics under state law because federal
law requires that the labels on generic drugs must match the labels on
their brand-name counterparts.

However, during the course of the Mensing litigation, it emerged that
PLIVA had failed to update the label on its gastric reflux drug,metoclopromide, to bring it in line with the brand version, Reglan, made
by Schwarz Pharma.